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Short Versus Long Axis Ultrasound Guided Approach for Internal Jugular Vein Cannulations

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ClinicalTrials.gov Identifier: NCT03130660
Recruitment Status : Completed
First Posted : April 26, 2017
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Shakti Bedanta Mishra, Institute of Medical Sciences and SUM Hospital

Brief Summary:
We plan to compare single person short axis view with two person long axis view

Condition or disease Intervention/treatment Phase
Ultrasonography Central Line Complication Device: Ultrasonography Not Applicable

Detailed Description:

Introduction: The guidelines for the use of bedside ultrasonography in the evaluation of critically ill patients published by the society of critical care medicine recommends short-axis view be used during insertion of central venous catheter (CVC) in internal jugular vein (IJV) to improve success rate1. The long axis view is considered better for cannulations as it helps in preventing posterior wall puncture but in the trials it has been found to be inconvenient for a single user2,3. We hypothesise that if two persons perform long axis cannulations i.e. one person will image the vein while the other punctures it will be equally convenient to single person doing the cannulations in short axis. The advantage we expect to see is lesser complications in long axis group.

Methodology:

Inclusion criteria: Any patient getting admitted to ICU and requiring central venous cannulations.

Exclusion: Lack of consent. Randomization: At a 1:1 ratio, to be achieved using a computer-generated random number sequence for 100 consecutive subjects Study intervention: Eligible patients will be randomized to a short-axis or long axis technique for ultrasound guided IJV cannulations. Ultrasound guidance will be performed dynamically using a single-operator technique for short axis and double operator technique for long axis view. Cannulations and USG is to be carried out by 2 trained Anaesthesiologists.

Definition:

  1. Insertion time: Time taken from 1st puncture of skin to insertion of guide wire into the vein.
  2. Total Procedure time: Time from when Ultrasound scan was started to complete suturing of the CVC line.
  3. Number of needle sticks: Number of time punctures were done in the skin. Complications were noted as hematoma formation, posterior wall puncture, arterial puncture, extravasations of blood and pneumothorax.

All the times are to be noted by a bedside nurse who is not involved in the trial or knows the study hypothesis.

Statistical Analysis: An intention-to-treat analysis was performed. Insertion time, overall procedure time and number of needle sticks, and will be compared using Mann-Whitney U tests. The success rate and complication rate will be compared using Fisher exact tests. All statistical analyses will be performed with SPSS 20.0


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: patient to be randomized to two groups
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Short Versus Long Axis Ultrasound Guided Approach for Internal Jugular Vein Cannulations: A Prospective Randomised Controlled Trial.
Actual Study Start Date : April 20, 2017
Actual Primary Completion Date : April 19, 2018
Actual Study Completion Date : April 19, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Short Axis Ultrasonography
one person does both ultrasound and line insertion
Device: Ultrasonography
Ultrasound guidance for central line

Experimental: Long Axis Ultrasonography
one person does ultrasound and another inserts the central line
Device: Ultrasonography
Ultrasound guidance for central line




Primary Outcome Measures :
  1. time to insertion [ Time Frame: 15 minutes ]
    time from skin puncture to insertion of guidewire


Secondary Outcome Measures :
  1. Total Procedure time [ Time Frame: 15 minutes ]
    Time from when Ultrasound scan was started to complete suturing of the CVC line.

  2. Number of needle sticks [ Time Frame: 15 minutes ]
    Number of time punctures were done in the skin

  3. Complications [ Time Frame: 48 hours ]
    hematoma formation, posterior wall puncture, arterial puncture, extravasations of blood and pneumothorax



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any patient getting admitted to ICU and requiring central venous cannulations.

Exclusion Criteria:

  • Lack of consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130660


Locations
India
IMS and SUM Hospital
Bhubaneswar, Odisha, India, 751007
Sponsors and Collaborators
Institute of Medical Sciences and SUM Hospital
Investigators
Study Director: Arun Rath, MD IMS and Sum hospital

Responsible Party: Shakti Bedanta Mishra, Associate Professor, Institute of Medical Sciences and SUM Hospital
ClinicalTrials.gov Identifier: NCT03130660     History of Changes
Other Study ID Numbers: DMR/IMS.SH/SOA/170022
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We havent decided yet

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shakti Bedanta Mishra, Institute of Medical Sciences and SUM Hospital:
central line
Central Line Complication